10xAnd
Scoping review

FDA product code · Ear, Nose, Throat · Class 2

LXB: Hearing Aid, Bone Conduction

LXB is FDA's product code for "Hearing Aid, Bone Conduction": a Class 2 device classified under 21 CFR 874.3302, reviewed by the Ear, Nose, Throat panel.

510(k) review time for LXB

Across 12 510(k) clearances under LXB decided from 2018-01-01 to 2026-10-06, the median was 125 days from FDA receipt to decision. Half took between 71 and 211 days, and 80% were decided within 213 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, LXB, decisions 2018-01-01 to 2026-10-06 (n = 12)
Fastest20
25th percentile71
Median125
75th percentile211
80th percentile213
90th percentile252
Slowest322

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

LXB in the public FDA record

Records naming LXB, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years53
Establishment listings103
GUDID device identifiers785

Counts of records, not of devices or events. Adverse event reports for LXB are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite LXB

10 FDA recognized consensus standards cite LXB, among them ANSI ASA S3.1-1999 (Reaffirmed 2023); ANSI ASA S3.4-2007 (Reaffirmed 2025); ANSI ASA S3.5-1997 (Reaffirmed 2024). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 4-160 ANSI ASA S3.1-1999 (Reaffirmed 2023) — American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
  • 4-162 ANSI ASA S3.4-2007 (Reaffirmed 2025) — American National Standard Procedure for the Computation of Loudness of Steady Sounds
  • 4-163 ANSI ASA S3.5-1997 (Reaffirmed 2024) — American National Standard Methods for Calculation of the Speech Intelligibility Index
  • 4-165 ANSI ASA S3.13-1987 (Reaffirmed 2024) — American National Standard Mechanical Coupler for Measurement of Bone Vibrators
  • 4-167 ANSI ASA S3.21-2004 (Reaffirmed 2023) — American National Standard Methods for Manual Pure-Tone Threshold Audiometry
  • 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2025) — American National Standard For Rating Noise with Respect to Speech Interference
  • 4-204 ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2025) — American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
  • 4-228 ANSI ASA S3.20-2015 (Reaffirmed 2025) — American National Standard Bioacoustical Terminology
  • 4-260 ANSI ASA S12.2-2019 (Reaffirmed 2023) — American National Standard for Criteria for Evaluating Room Noise
  • 4-274 ANSI ASA S3.2-2020 (Reaffirmed 2025) — American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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